BRPI1105212A2 - Automated workstations for aseptic liquid collection and collection devices - Google Patents

Abstract

Automated workstations for aseptic fluid collection and collection devices. An automated liquid collection workstation is described. The workstation includes a processor, a peristaltic pump, a valve actuator, and an algorithm. The peristaltic pump and valve actuator are in electrical communication with the processor. The valve actuator may move a plurality of valves, when arranged in this place, between an "off" position, a "flow" position, and a "retract" position. The algorithm is inside the processor and is configured to: move all valves to the "off" position and place the pump in "off" state when no flow or collection is required, move all valves to the "flow" position and place the pump in a running state for a predetermined flow time when a flow is required, and move one of its valves to the "pickup" position, move any of the valves upstream of their valve to the "flow" position , and place the pump in an on state for a predetermined collection time period when a collection is required.

Description

"AUTOMATED WASTE COLLECTION WORKSTATIONS AND EVEN COLLECTION DEVICES" This request is a continuation-in-part of request no. US 12 / 959,647, filed December 3, 2010, now pending, the full contents of which are incorporated herein by reference. The present invention relates to automated aseptic liquid collection workstations. More specifically, the present invention relates to workstations for use in automated liquid collection during processing, as well as collection devices used with such automated workstations.

Description of the state of the art Many liquid products can be processed in a sterile and / or aseptic environment to protect the product and / or manufacturing personnel from contamination. Such liquid products include, but are not limited to, pharmaceuticals (eg, medicines and vaccines), food, biological, biochemicals, chemicals and any combinations thereof. It is known to collect liquids during processing. The collected liquid can be used as a sample or to test the liquid before, during and after some processing steps to ensure that the resulting product meets various acceptance criteria. Similarly, the collected liquid may be a finished product, such as, inter alia, a collected centrifuged fraction, or the precursor of a finished product. In addition, the collected liquid can be collected in any desired volume.

In some cases, liquid collection may be performed during or after some process phases and / or some time intervals. In other cases, collection may be performed after the product has been manufactured, but before the production batch is released for use by consumers.

Important: Collecting liquids from the processing line is a critical activity and creates a potential risk of product and / or sample contamination. Unfortunately, the risk of contamination generally leads manufacturers to limit the number of times liquids are collected and / or to limit the number of locations where such liquids are collected.

In addition, when collecting test samples from the product, sample contamination may cause a false result, which may lead to unnecessary destruction of a batch of product and / or unnecessary delay in the continuation of the production process until the cause of contamination. be determined.

In addition, the need to clean and sterilize the sample path before and / or after each batch usually requires sampling devices to be made of rigid tubes at a specific location on the production line, which may limit the flexibility of the sample line. processing to process other products in a timely and efficient manner.

In addition, containers of collected liquids must be properly identified by the operator and this identifying information must then be entered by the department responsible for testing the sample or releasing the finished product. Manual identification of collected liquid containers and manual insertion of this identity is proven to be error-prone, which can then complicate proper testing and product release.

Thus, it has been determined by the present invention that there is a need for workstations that can overcome, alleviate, and / or alleviate one or more of the other harmful effects of the current practice mentioned above. For example, it has been determined by the present invention that there is a need for workstations that automate the collection of liquid products, while ensuring integrity and eliminating the risk of contamination, and minimizing errors regarding manual input of data related to the collected liquid.

OBJECTS AND BRIEF DESCRIPTION OF THE INVENTION A device for collecting liquids is provided. The collection device includes an inlet conduit, a plurality of automated product collection containers, a waste collection container, and a valve lock. The inlet conduit is connectable to a liquid processing line. Product collection containers have one product volume each, and the waste collection container has a volume of waste. The valve lock consists of a plurality of three-way valves and an outlet, where the plurality of three-way valves correspond in number to the plurality of product collection containers, each of the three-way valves placing the inlet conduit into net communication with one of the different product collection containers. The output is in liquid communication with the waste collection container. The collection device has a waste volume to product volume ratio of no more than 15: 1.

An automated workstation for liquid collection is provided. The workstation includes a processor, a peristaltic pump, a valve actuator, and an algorithm. The peristaltic pump and valve actuator are in electrical communication with the processor. The valve actuator may move a plurality of valves, when arranged in this place, between an "off" position, a "flow" position, and a "retract" position. The algorithm is inside the processor and is configured to: move all valves to the “off” position and place the pump in “off” state when no flow or collection is required, move all valves to the “flow” position and It is necessary to place the pump in an on state for a predetermined flow time, and move one of its valves to the “pickup” position, move any of the valves upstream of their valve to the “flow” position, and set the pump in an on state for a predetermined period of time when a collection is required. A method for automatically taking a plurality of liquid collection from a processing is provided. The method includes: cleaning a processing line that has the first half of a two-part connector connected to it; connecting the second half of the two-part connector to a liquid collection device, which has a variety of collection vessels, a valve block, and an inlet conduit with the second half of the two-part connector; the valve lock has an inlet, a plurality of three-way valves and an outlet; the plurality of three-way valves correspond in number to the plurality of collection vessels; each of the three-way valves places the inlet in liquid communication with a different collection container, and the outlet is in liquid communication with a waste collection container; the admission is in net communication with the admission conduit; and inserting the valve lock into a valve actuator such that a key of each of the various valves is removable by the valve actuator. Also provided is a method of automatically taking a plurality of liquid collection from a processing line, including: placing an inlet conduit of a liquid collection device in liquid communication with the processing line; operatively connecting the inlet conduit to a peristaltic pump and to a valve block inlet with a plurality of three-way valves; operatively connecting the valve lock to a valve actuator such that each of the plurality of three-way valves is movable by a different portion of the valve actuator between an "off" position, a "flow" position, and a position "collect"; valve actuator control to move the plurality of three-way valves to the “flow” position and turning on the peristaltic pump so that process line liquids are pumped through the valve lock to a communicating waste container liquid with a valve block outlet; and controlling the valve actuator to move a specific valve from the plurality of three-way valves to the "pickup" position and to move any of the plurality of three-way valves to the specific valve mount to the "flow" position while the If the peristaltic pump remains on, the specific valve is associated with a specific collection container so that process line liquids are sprayed through the valve lock to the specific collection container.

The features and advantages described above and others of the present disclosure will be appreciated and understood by those skilled in the art from the following detailed description and drawing.

Brief Description of the Drawings Figure 1 is a top perspective front view of an exemplary workstation configuration in accordance with the present invention; Figure 2 is a top front view of the workstation of Figure 1; Fig. 3 is a top view of the workstation of Fig. 1; Figure 4 is a top perspective front view of an exemplary configuration of a collection portion of the workstation of Figure 1; Fig. 5 is a perspective view of an exemplary configuration of a liquid collection assembly according to the present invention for use with the workstation of Fig. 1; Fig. 6 is a perspective view of an exemplary valve lock configuration in accordance with the present invention for use in the liquid collection assembly of Fig. 5; Fig. 7 is a flow chart illustrating an exemplary embodiment of a liquid collection method according to the present invention; Fig. 8 is a flowchart illustrating an exemplary embodiment of a method of verifying a collection device in accordance with the present invention; and Figures 9a to 9c illustrate alternative exemplary configurations of liquid collection containers and / or waste collection containers for use with the liquid collection set of figure 5.

Detailed Description of the Invention With reference to the figures, and in particular to FIGS. 1 to 4, an exemplary configuration of an automated aseptic fluid collection workstation according to the present disclosure is shown, and is generally termed using reference numeral 10. Workstation 10 is configured to collect, label and automatically and aseptically store in a liquid collection device 12 (shown in FIG. 5) a variety of liquid collection from a processing line or vessel (A). Workstation 10 is configured to automatically collect liquids such as, but not limited to, pharmaceuticals (eg, medicines and vaccines), food, biological, biochemicals, chemicals and any combinations thereof. The collected liquid can be used as a sample, as an intermediate product or as a finished product.

Conveniently, workstation 10 is flexibly configured, so configured that the workstation can be moved from point to point, and / or from one process step to another process step in a manufacturing process. In addition, workstation 10 is preferably suitable for use in an aseptic environment or a clean room, so that material selection (eg stainless steel or other material) and material specifications (eg surface finish) are sufficient for use in such environments. Workstation 10 includes a base or cabinet 14 supported in some configurations by a plurality of wheels or casters 16 such that the workstation is movable and may be positioned as desired at various locations within a workstation. processing. Workstation 10 includes a collection portion 18 for pumping liquids into the collection device 12. Collection portion 18 includes a pump 20, a valve actuator 22, in some configurations, a liquid side detector 24, and a plurality of areas for holding liquids 26. Pump 20 may be any desired pumping device, but is preferably a non-contacting pump that selectively withdraws liquids without direct contact with the liquid itself. In an ideal configuration, pump 20 is a peristaltic pump. The liquid side detector 24 may be any desired detector such as, but not limited to, a sonic or capacitance detector, or any other contact or non-contact sensor, to determine the presence or absence of liquids in one or more areas of the device. 12. The detector 24 may be in electrical communication with the workstation 10 so that the workstation can detect when liquids are present at a predetermined location in the liquid collection device 12.

As seen in FIG. 5, liquid collection device 12 includes a plurality of product collection containers 28 (six shown), at least one waste container 30 (only one shown), and a valve lock 32. Product containers 28 may be configured to have any desired volume so that the product container volumes are identical and / or different from each other.

Product collection containers 28 and waste container 30 may be any desired collection container such as, but not limited to, collection bags as shown in FIG. 5. For example, containers 28 and 30 may be collection pouches such as Allegro ™ 2D Biocontainer, which are commercially available from Pall Corporation. In this configuration, each container 28 and 30 includes an inlet line 29 sealed with a removable clamp 33, an outlet line 31 sealed with a removable clamp 33, and a port 35.

Of course, it is contemplated by the present disclosure that containers 28 and 30 are sterile collection containers including, but not limited to, collection bottles, collection boxes, collection syringes, etc.

In the illustrated embodiment, the liquid collection device 12 includes five automated product collection containers 28 of identical volumes, eg, about 50 milliliters (mL), and a larger volume manual collection container 28 of about 500 ml. In addition, in the illustrated embodiment, the liquid collection device 12 includes a waste container 30 of about 1,000 mL. Obviously, it should be recognized that the number and volumes of containers 28 and 30 can be modified to any desired size. Device 12 also includes an inlet conduit 34 configured to place a processing line in liquid communication with valve block 32.

Inlet conduit 34 includes at least one flexible portion 36. The portion 36 is configured to operably fit with the pump 20 so that the pump may force liquid into the containers 28 and 30 of the liquid collection device 12 In the example where pump 20 is a peristaltic pump, flexible portion 36 is made of material having sufficient resilience (e.g., a silicone tube) to operate in cooperation with the peristaltic pump. The liquid collection device 12 is usable with one or more aseptic two-part connectors 38. In the illustrated embodiment, inlet conduit 34 has only one part 38-1 of a two-part connector 38 connected to it. The mating portion 38-2 for the two-part connector 38 of the inlet conduit 36 is in liquid communication with the processing line or vessel A.

In this manner, the liquid collection device 12 may be connected to the processing line or vessel by joining both halves 38-1 and 38-2 of the two-part connector 38 to the inlet conduit or to the processing line or vessel. In order to maintain sterility, the two-part connector portion 38-2 in conjunction with the production line or vessel A may be sterilized or sanitized together with the production line or vessel prior to processing the liquid. The two-part connector 38 may be any disposable two-part aseptic connector such as, but not limited to, the Kleenpak ™ connector, which is available for sale through Pall Corporation, the Opta * SFT-I connector, available for sale from Sartorius. Stedim Biotech, the Lynx® ST Connector, available for sale through Millipore Corporation, and the AseptiQuik ™ Connector, available for sale through Colder Products Corporation.

In some configurations of the liquid collection device 12, product collection containers 28, waste collection container 30, and valve lock 32 are removably connected to each other. For example, the liquid collection device 12 may include a plurality of connectors 39 such as but not limited to Luer lock connectors.

All product contact surfaces within the collection device 12 are made of any material sufficient to hold or contact the liquid without interacting or contaminating the liquid. In addition, the collection device 12 may be packaged in one or more outer packages (not shown), and may then be sterilized using known sterilization methods such as, among others, gamma ray irradiation. In this way, the collection device 12 may remain in sterile condition until ready for use. Valve lock 32 as shown in FIG. 6 includes an inlet 40, a waste outlet 44, and a plurality of three-way valves 46 (six shown). Intake 40 is in liquid communication with inlet conduit 34 and waste outlet 42 is in liquid communication with waste collection container 30.

The various three-way valves 44 correspond in number to the plurality of collection vessels 28, with an outlet 46 of each valve in liquid communication with one of the different collection vessels 28.

Each of the three-way valves 44 is rotatable by rotating a valve wrench 48 between three positions: a "off" position: a "flow" position; and a "collecting" position.

In the "off" position, each valve 44 prevents inlet liquid 40 from flowing through the valve to the waste outlet 42 or outlet 46. In the "flow" position, each valve 44 allows inlet liquid 40 to flow out. through the valve towards the waste outlet 42, but prevents it from flowing towards the respective outlet 46. In the "pick up" position, each valve 44 allows inlet liquid 40 to flow through the valve toward its outlet 46, but prevents leakage towards waste outlet 42. Switch 48 of each valve 44 operatively fits a different portion of valve actuator 22 so that the valve actuator can selectively rotate each switch independently of each other In this way, workstation 10 via valve actuator 22 is configured to activate valve lock 32 to selectively divert liquid from the line. or processing vessel into any of the collection containers 28 or the waste container 30.

Referring now to Table No. 1 below, the relative positions of valves 44 are provided during the various sampling activities contemplated by the present invention.

Here, the plurality of valves 44 are numbered sequentially in the direction of liquid flow, valves 44-1 to 44-6 and collection vessels 28 are numbered sequentially in the direction of liquid flow as containers 28- 1 to 28-6.

As seen in Table No. 1 above, when the liquid collection device 12 is not in use, all valves 44 are rotated to the "off" position, preventing liquid communication through valve lock 32.

Prior to collection and / or whenever it is desired to flow or fill the liquid flow path within the liquid collection device 12, each of the valves 44 may be rotated to the "flow" position, placing the inlet 40 in liquid communication with each other. outlet 42. In this way, the liquid from the inlet conduit 34 is diverted to the waste container 30.

When it is desired to divert the liquid to a particular collection container 28, the specific valve 44 associated with the specific container 28 is placed in the "collection" position. In addition, any upstream valve with respect to liquid flow through valve block 32 is moved to the "flow" position. Preferably, any downstream valve 44 with respect to the flow of liquid through valve block 32 is moved to the "off" position. However, these downstream valves 44 may have any desired condition.

When bypass to a specific collection container 28 is complete, valves 44 are returned to the "off" position.

During use, the liquid collection device 12 is positioned at the workstation 10 so that the flexible portion 36 of the inlet conduit 34 is operatively positioned at the pump 20 and so that the valve lock 32 is positioned at operatively to valve actuator 22. When liquid is being processed through the production line or vessel, the half of the two-part connector 38 in inlet conduit 34 is operatively connected to its conjugate half disposed in the line or vessel. Valve actuator 22 may be used by the operator to operate valves 44 manually. For manual operation, workstation 10 includes one or more buttons and valve operating controls 48.

Otherwise, and in a preferred embodiment, valve actuator 22 may be automatically controlled by workstation 12 as described in more detail herein below. Of course, it is provided by the present invention that the valve actuator 22 is controlled by any combination of manual and automated controls.

It has been determined by the present invention that workstation 10, due in part to the use of two-part aseptic connectors 38 in combination with liquid collection device 12, may be selectively moved from point to point within the manufacturing process to perform desired sampling as needed. In addition, workstation 10 may be installed at a particular location within the manufacturing line when this line is assembled to make a first product, but may be relocated to a different location within the manufacturing line when this line is assembled. to make a second product. In other words, workstation 10 may reduce equipment costs to monitor a manufacturing process by being used at various locations within the manufacturing line during a production operation or by being repositioned to a different stationary position when the line is manufacturing is reconfigured to accommodate the manufacture of different products. Workstation 10 may, in some embodiments, include a waste and product container holding area 50, which may hold containers 28 and 30 in a desired position and / or desired conditions, suitable for the liquid contained therein. For example, workstation 10 may include sufficient environmental controls to maintain containers 28 and 30 and thus the liquid contained therein at a desired temperature. In other examples, workstation 10 may include sufficient stirring and / or vibration devices to hold the liquid within containers 28 and 30 in mixed or agitated state. Workstation 10 may include one or more sensors 52 for monitoring and recording conditions (eg, temperature, humidity) within base 14, conditions within containers 28 and 30 (eg, temperature, turbidity, volume). , etc.), and other workstation conditions. In addition, workstation 10 may include sensors or may connect to sensors outside of workstation 54 to monitor and record off-base 12 conditions including but not limited to temperature, pressure, humidity, particles, and detection, typing and monitoring of viral and / or microbial organisms.

It is provided by the present invention that workstation 10 coordinates control of pump 20, valve actuator 22, liquid side detector 24 and sensors 50 within workstation 10, as well as signal and data collection. from any other human / machine input device (wireless or hardwire connected) 56 such as, but not limited to, keyboards, touch screens or any other data communication device, USB ports or other data communication ports, CD or other devices for reading data, computers, PLCs, analysis equipment, test devices, and sensors off the workstation.

In some configurations, the liquid collection device 12 may include a disposable flow meter 58 in electrical communication with the workstation 10.

Thus, workstation 10 may include a processor 60 having a human machine interface (HMI) 56 with one or more input devices 62 and one or more output devices 64. Processor 60 may include devices such as others, a computer, a programmable logic controller (PLC), or any other processor suitable for controlling the different components of workstation 10. The HMI 56 may include, for example, a keyboard, mouse, barcode reader , a touch screen, a USB port or other data communication port, a CD or data reading device, a remote control, or any other data communication device suitable for input commands to processor 60 in a connected manner, and / or wireless, and any combination thereof. The output device 64 may include a computer monitor, an audible alarm device, a visual alarm device, a printer, a USB port or any other data communication port, a CD or other data recording device, a data communication device (wireless or wired) or any other device suitable for receiving a wired and / or wireless output from the processor 60.

In a preferred embodiment, the HMI 56 includes at least one barcode reader 62 and the liquid collection device 12 may include at least one machine readable label 66 which will include details about the liquid collection device such as, among others, the batch number, expiration date, product and waste container number 28 and 30, volume of product and waste container 28 and 30, the volume of conduit within the collection device, and Other details. In use, the operator will be able to scan the machine readable label 66 of the liquid collection device 12 using the barcode reader 62 so that the processor 60 can determine and record different details regarding the liquid collection device. 12

Furthermore, it is provided by the present invention that output devices 64 include at least one printer. Processor 60 controls printer 64 to print labels, which can be applied by the operator directly to each container 28 and 30, and includes information that is relevant to the liquid contained in the container. For example, processor 60 may control printer 64 to print information such as, but not limited to, the date of collection, the time of collection, the operator, batch ID, program sequence, room number, station number, collection site, and other environmental or process variables.

Preferably, the printer 64 is configured to print label information in a machine readable language, such as bar code, so that a lab technician can scan the machine readable code for input of all relevant data related to the machine. inside the container, which can attenuate error occurrences by entering data. Processor 60 is in electrical communication by some means wired or wireless such as, but not limited to, electrical, optical, audible, infrared, radio frequency, magnetic and other media with any of the pumps 20, the actuator. valve 22, the level 24 sensor, manual controls 48, sensors 52 and 54, HMI 56, flow meter 58, output devices 60, as well as a barcode reader 62 and a printer 64.

In this manner, processor 60 is configured to coordinate control of workstation 10 and liquid collection in collection device 12, as well as to provide label information for placement in container 28, 30.

In some examples, processor 60 may communicate wirelessly and / or wirelessly with one or more computers (not shown) outside of workstation 10, where such external computers may include data collection, data archiving, analysis. and data management software. The aseptic liquid collection capacity of workstation 10 and collection device 12 mitigates or eliminates the risk of contaminating the collected liquid or processing line. Workstation 10, via processor 60, may be programmed to aseptically obtain one or a series of randomly taken liquid collection at selected times or at preset times with manually selected volumes or preset volumes.

Now with reference to FIG. 7, a method 70 of operating the workstation 10 having a liquid collection device 12 is shown.

In a first step or selection step 72, the appropriate liquid collection device 12 for the desired collection is selected by the operator.

In a second assembly step or step 74, the operator assembles the selected liquid collection device 12 at workstation 10. More specifically, containers 28 and 30 are placed in area 50, valve lock 32 is operatively positioned in the valve actuator 22, and flexible portion 36 of inlet conduit 34 is operatively positioned on pump 20. When liquid side level detector 24 is present, a portion of inlet conduit 34 is operatively positioned on the detector.

In a third verification step or step 76, the operator enters liquid collection device 12 related information into processor 60 and enters desired processing line or vessel related information from which the workstation 10 will collect the liquid. In some configurations, verification step 76 includes requiring the operator to use scanner 62 to scan bar code 66 on the liquid collection device 12.

Once the processor 60 checks the liquid collection device 12, the processor sends a result to the operator in a fourth connection step or step 78 to instruct the operator to put the liquid collection device in liquid communication with the operator. HMI processing line or vessel 56. As discussed in detail above, the liquid collection device 12 is placed in liquid communication with the processing line or vessel by interconnecting the two-part connector 38.

When liquid is present in the processing line or vessel, the operator initiates a desired collection sequence from workstation 10 during step 80. Step 80 may initiate a manual collection process 82 using manual controls 48. Otherwise Thus, step 80 may initiate an automated collection process using an algorithm 84 internal to processor 60.

During automated collection, algorithm 84 is configured to activate pump 20, to force liquid from the processing line or vessel through inlet conduit 34 and valve block 32 and inwards as desired or from container 28 or of waste container 30.

Prior to taking each collection, algorithm 84 is configured to control workstation 10 for a flow step 86. During flow step 86, algorithm 84 drains or purges liquid through the liquid collection device 12 inwards. waste container 30 for a predetermined period of time by moving all valves 44 to the "flow" position.

Then, after the predetermined purge or flow from step 86, algorithm 84 initiates a collection step 88, in which processor 60 moves the various valves 44 in the manner discussed above with respect to Table No. 1. 1 to divert a desired volume of liquid into the desired collection vessel 28.

After a predetermined volume of liquid has been diverted into the selected collection vessel 28, algorithm 84 completes collection step 88 by disabling pump 20 and returning valves 44 to the "off" position. Algorithm 84 repeats flow and collection steps 86 and 88 to enable pump 20 to flow liquid within the liquid collection device 12 to waste container 30, divert liquid to desired product container 28, deactivate pump, and close the valves until all desired liquid collection has been achieved.

In configurations where liquid collection device 12 includes a flow meter 58, algorithm 84 may use flow meter inputs to ensure proper liquid and purge volumes. Likewise, in configurations where workstation 10 includes a liquid side sensor 24, algorithm 84 may use sensor inputs to ensure adequate liquid and purge volumes.

Preferably, algorithm 84 is also configured to enable printer 64 to print data on a label when a respective liquid collection is obtained during a printing step 90. The operator can then apply the label to the appropriate container 28, respectively. Similarly, algorithm 84 can be configured to enable printer 64 to print waste related data on a label when the waste is collected, or after all waste has been collected.

During the manual collection process 94, the operator may manually and / or via controller 60 transfer the liquid collection device 12 to the waste container 30 during a manual flow step 96 and divert a desired volume of liquid to the manual container 28, when present, during the manual collection step 98.

Once liquid collection is achieved, the operator may, during a disconnect step 92, disconnect the liquid collection device 12 from the processing line or vessel by separating the two-part connector 38. In the same manner, the operator may remove each product container 28 and waste container 30 of the liquid collection device 12, separating the two-part connector 38.

Conveniently, algorithm 84 purges a predetermined amount of liquid from the liquid collection device 12 prior to each liquid collection to ensure that the liquid collected in the product container 28 represents the liquid in the currently processing line or vessel. of the collection. In order to perform the desired purge, the waste container 30 has a volume that is sufficient to contain the purged liquid. In the illustrated embodiment, a ratio of volume of waste container 30 to volume of product container 28 is not greater than 15: 1, preferably 10: 1, and is ideally between 5: 1 and 2: 1. In this manner, the waste container 30 provides sufficient volume to allow the liquid collection device 12 to be drained prior to each collection to ensure that the liquid collected in the product container 28 represents the liquid in the processing line and, if not, the liquid remaining within the diverted anterior fluid collection device.

Referring now to FIG. 8, an exemplary configuration of method 70 verification step 76 is now shown in more detail. During verification step 76, processor 60 requires the user to scan the bar code 66 on the liquid collection device 12 using a scanner 62 in one scanning step 100.

In some configurations prior to scan step 94, method 70 may also include a process identification step 102, where parameters and / or details of the process and / or liquid to be collected are entered into processor 60. Parameters and / or details can be manually entered into processor 60 by the operator, can be scanned to processor 60 using scanner 62 and an identifier located on the batch register and / or process equipment, or any combination of manual and scanned data entry. Verification step 76 determines, based on data in processor 60 and barcode information 66, whether liquid collection device 12 is new or was previously used in a step 104. If liquid collection device 12 has been used previously, verification step 76 returns the user to assembly step 74 so that a new collection device can be used.

If the liquid collection device 12 is new, verification step 76 compares the details of the liquid collection device (eg, container size and number 28 and 30) for the collection protocol stored on processor 60 for the process to be monitored in step 106. If liquid collection device 12 is not correct for the desired collection profile, verification step 76 returns the user to assembly step 74 so that a correct collection device can to be used.

If the liquid collection device 12 is correct, verification step 76 records the liquid collection device 12 as previously used in processor 60 in step 108, and instructs the operator in connection step 78 to place the device. of liquid collection in liquid communication with the processing line or vessel via HMI 56.

As discussed in detail above, the liquid collection device 12 is placed in liquid communication with the processing line or vessel by interconnecting the two-part connector 38.

As discussed above, containers 28 and 30 are described as pouches. However, it is provided by the present invention that containers 28 and 30 are any desired sterile container. Referring now to FIGS. 9a to 9c, alternative exemplary embodiments of containers 28 and 30 are shown, and are indicated using multiples of one hundred.

In FIG. 9a, containers 228 and 230 are illustrated as a fluid-containing carry case. Containers 228 and 230 may be permanently or removably connected to liquid collection device 12. When removably connected, containers 228 and 230 include a connector 239 such as, but not limited to, a Luer lock connector for connecting the liquid collection device 12.

When containers 28 and 30 are pouches, containers are usually unventilated pouches that may expand as fluid is diverted to the pouch by the workstation 10. However, containers 228 and 230 are rigid enough that the container it may also include a sterile vent 240. Vent 240 allows gas within containers 228 and 230 to escape from the container as liquid is diverted to the container. In addition, vent 240 preferably prevents gas from outside containers 228 and 230 from entering the container and prevents liquid inside the container from escaping from the container. Vent 240 can be any sterile vent such as, but not limited to, PHARMAVENT vent and Fine Spike vent, both available for sale through CliniMed Holdings Limited.

Of course, it should be recognized that it is provided by the present invention that flexible pouches include a sterile vent in them as required.

In FIG. 9b, containers 328 and 330 are illustrated as a fluid containing bottle. Again, the containers 328 and 330 may be connected to the liquid collection device 12 and may therefore optionally include a connector 339 to connect to the liquid collection device. In addition, the containers 328 and 330 are rigid enough that the container also includes a sterile vent 340, as discussed above.

In FIG. 9c, containers 428 and 430 are illustrated as a fluid containing syringe. Again, containers 428 and 430 may be permanently or removably connected to the liquid collection device 12 and may therefore optionally include a connector 439 to connect to the liquid collection device.

Containers 428 and 430 include a chamber 442 with a slidably received piston 444. Prior to use, piston 444 is pressed into chamber 442 such that a volume of gas within containers 428 and 430 is minimized. As workstation 10 diverts liquid into containers 428 and 430, piston 440 is pushed or slid into chamber 442 such that the fluid-containing syringe does not require a separate vent.

As described, the liquid collection containers for both products and waste may be any flexible or rigid container, bottle or carpule that allows liquid to divert into the container, while allowing gas within the container to vent or allow allow the container itself to expand or move to accommodate the inlet liquid.

It should also be noted that the terms "first", "second", "third", "upper", "lower" and the like may be used here to modify various elements. These modifiers do not result in a special, sequential, or hierarchical order for the modified elements unless specifically defined.

While the present invention has been described with reference to one or more exemplary embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the present disclosure. In addition, many modifications may be made to adapt a specific situation or material to the teachings of the invention without departing from the scope thereof. Therefore, it is intended that the present invention be not limited to the specific configuration (s) disclosed as the best contemplated model, but that the invention include all configurations falling within the scope of the present invention.

Claims (17)

1. A liquid collection device comprising: an inlet conduit connectable to a liquid processing line; a plurality of product collection containers each containing a volume of product; a waste collection container containing a volume of waste; a valve block containing a plurality of three-way valves and an outlet, wherein said plurality of three-way valves correspond in number to said plurality of product collection containers, each of the three-way valves placing the inlet conduit in liquid communication with one of the different product collection containers, and said output in liquid communication with the waste collection container, and a waste volume to said product volume ratio of no more than 15: 1. The liquid collection device of claim 1, characterized in that the ratio is 10: 1. The liquid collection device of claim 1, characterized in that the ratio is between 5: 1 and 2: 1. The liquid collecting device of claim 1, further comprising a machine readable label on said valve lock, said machine readable label containing information related to the physical characteristics of said liquid collecting device. . The liquid collection device of claim 4, characterized in that the physical characteristics are selected from the group consisting of a batch number, an expiration date, a number of such product collection containers, a volume of each of such product collection containers, a volume of such waste collection container, and any combinations thereof. The liquid collection device of claim 1, characterized in that it also comprises a first part of a two-part aseptic connector in a mentioned inlet conduit. The liquid collection device of claim 1, characterized in that it also comprises a disposable flow meter in said inlet conduit. The liquid collection device of claim 1, wherein said product collection containers and said waste collection container are containers selected from the group consisting of a pouch, a vented bottle, a vented syringe, and any combinations thereof. 9. An automated liquid collection workstation comprising: a processor; a peristaltic pump in electrical communication with such a processor; a valve actuator in electrical communication with such a processor, and the valve actuator being configured to move a plurality of valves, when disposed therein, between an "off" position, a "flow" position, and a "retract" position; and an algorithm within such a processor, which is configured to: move said plurality of valves to the "off" position and place such a pump in an off state when no collection or flow is required, to move said plurality of valves to the "off" position. "Flow" and bring such a pump into a switched state when a predetermined flow time is required, and move a respective said plurality of valves to said "collect" position, move any of the plurality of valves upstream of respective to the “flow” position, and place such a pump in such an on state for a predetermined collection time period when a collection is required. The liquid collection workstation of claim 9, further comprising a barcode scanner in electrical communication with such a processor. The liquid collection workstation of claim 9, further comprising a label printer in electrical communication with such a processor. The liquid collection workstation of claim 9, further comprising a liquid side detector in electrical communication with such a processor. The liquid collection workstation of claim 9, characterized in that it also comprises a sensor in electrical communication with such a processor, and with such a processor configured to detect an environmental condition. The liquid collection workstation of claim 9, further comprising a base supported by a plurality of wheels, on which processor, peristaltic pump, and valve actuator are arranged on such a base. The liquid collection workstation of claim 14, wherein said base also comprises a waste and product container retention area which can hold the waste and product container in a desired position. and / or desired conditions suitable for the liquid contained therein. A method for automatically collecting liquids from a processing line comprising: placing an inlet conduit of a liquid collecting device in liquid communication with the processing line; operating connection of such inlet conduit to a peristaltic pump and to a valve block inlet with a plurality of three-way valves; operating connection of such a valve lock to a valve actuator, such that such a plurality of three-way valves are removable by a different portion of such valve actuator between an "off" position, a "flow" position, and a position "collect"; controlling such a valve actuator to move the plurality of three-way valves to such a "flow" position, and connecting such a peristaltic pump so that liquid from such a processing line is pumped through such a valve lock to a waste container in liquid communication with an outlet of such a valve lock; and controlling such a valve actuator to move a specific valve from such a plurality of three-way valves to such a "pickup" position, and to move any of the plurality of three-way valves upstream of such a specific valve to such a "flow" position. ”, While such a peristaltic pump remains on, with such a specific valve being associated with a specific collection vessel, such that liquid from such a processing line is pumped through such a valve lock to such a specific collection vessel. The method of claim 16, characterized in that it also comprises such a valve actuator for moving any of said pluralities of three-way valves downstream of such a specific valve to such an "off" position.